GVAX Cancer Vaccine Trial Procedure

Important Information for ASPS Patients Who Want to Join the Cancer Vaccine Clinical Trial at The Dana Farber.

(released by the Dana Farber Cancer Institute, Boston)
Dear Patient, if you feel you want to participate in the Cancer Vaccine Clinical Trial at the Dana Farber in Boston, please proceed in the work flow as follows:
1. Patient contacts his/her primary oncologist to review eligibility.
2. Patient asks his/her Primary oncologist to contact Dr. John Goldberg (e-mail: john_goldberg@dfci.harvard.edu ), who also consults with a medical oncologist from the Sarcoma Team at the Dana Farber Cancer Institute (DFCI).
3. If, on preliminary review, it is appropriate for the patient to undergo consideration for the trial, the New Patient Coordinator works with the Research RN to schedule a New Patient Consult.
4. At the New Patient Consult, the patient meets with a medical oncologist and possibly an NP and RN from the Sarcoma Team.
5. If it appears that the patient may be eligible, the patient will have a “informed consent ” session with the Sarcoma Medical Oncologist. During this conversation they will review the informed consent document together, discuss in detail, the treatment plan as
well as risks associated with the therapy and what the alternatives may be. The patient and family will have opportunities to ask questions regarding all aspects of their care. If they decide to proceed, they will sign the consent form, which then allows us to initiate formal screening for the clinical trial. This is coordinated by the Research RN and the CRC. A very important point here is that signing the consent in no way is a guarantee that patients will be able to participate in the trial.
If, during the screening process they are found to be “ineligible”
according to the protocol document, then they will not be able to
participate.
6. The screening involves history and physical exam, blood tests, CT or MRI scans and a review of pathology slides. This process can be complex and sometimes divided into a couple of visits depending on the circumstances.
7. Social work – Every patient who comes to DFCI has a social worker available to him/her. This team provides psychosocial support to the patients and families as well as serving to guide them in accessing a multitude of social needs. They frequently assist with
direction in addressing financial concerns, housing, transportation
etc.
8. Research Nurse – the study research nurse works closely with the clinical research coordinator to schedule all of the appointments and studies, pull it all together for review by the MD and coordinate the visits.
This person is an excellent resource for questions and concerns regarding logistics of participating in the trial.
9. Care Coordination – Every patient who comes to DFCI has access to a “Care Coordination” specialist. This person can also assist with direction in financial concerns, housing, transportation etc.
10. Financial – This trial is referred to as an “Investigator Initiated/Investigator Sponsored” trial. It is not financed by an outside pharmaceutical company. There is no provision for reimbursement of patients for travel, housing or any aspects of their care at DFCI. The patient’s insurance company is billed for all standard services provided by DFCI. The experimental portion of the
study (Vaccine preparation) is not billed. This topic is also covered
in the informed consent form.
11. Vaccine preparation – the patient will undergo a surgical procedure at CHMC or BWH to remove tumor for vaccine preparation. It takes a little over 2 weeks for the vaccine to be ready for injection. This is all reviewed in detail during the consent session however, there are a few other points to consider. On the day of surgery, patients are generally instructed to arrive at BWH 2 hours prior to their scheduled procedure. While the OR team will give the patient a specific time to report, it is very likely that their case will actually begin later than that scheduled time. This is due to the fact, that any operation that has preceded them may take longer than anticipated, therefore all following cases are moved to later in the day. This is a standard occurrence in the operating room and should not be a cause for alarm on the part of the patient. If they have questions or concerns when they are in the pre-operative waiting area, they always have a nurse assigned to them who can give them updates on what is happening. The surgeon performing their operation is frequently not available to come out and speak with them because they are in the operating room caring for a patient whom they can not leave at that time. Patients and families should always plan that the time waiting to begin the operation and often the time in the operating room is often much longer than initially presented.
12. The laboratory that prepares the vaccine also prepares the vaccines for all of the other DFCI vaccine trials as well as processing all of the bone marrow transplants for DFCI and Children’s Hospitals. They also process all of the other immunotherapy cellular products for DFCI. Therefore, their schedule is extremely tight and complicated. Patients may notice this when there are delays or changes in the timing of surgery because we have to coordinate the availability of laboratory space and staff with availability of operating room and surgeon time. In general, this works quite smoothly, however, occasionally we do need to make adjustments in the schedule which may affect travel arrangements.
13. Vaccine administration and skin biopsies – As reviewed in the consent process, the vaccine is administered weekly for 3 weeks and then every 2 weeks until the supply of vaccine is exhausted. The vaccine will be administered by one of the sarcoma MDs or NPs. At the time of vaccines 1 and 5 patients may receive a second injection
referred to as “DTH”. The DTH injection is made up of tumor cells that have been irradiated so that they can not grow, but they do not secrete GM-CSF as the vaccine cells do. These very important injections help us learn more about how the immune system is reacting to the vaccine. 2-3 days after vaccine and DTH 1 and 5 patients will undergo a small skin biopsy. The tissue form this skin biopsy will be examined by a pathologist and is very important in helping us learn about what the immune system “sees” when we give vaccine.